Device and method to reduce ear wax clogging of acoustic ports, hearing aid sealing sytem, and feedback reduction system

ABSTRACT

Devices and methods to reduce ear wax clogging of acoustic ports, hearing aid systems, and feedback reduction systems are provided. A conformal hearing aid includes a hearing aid body, where the hearing aid body houses a microphone and a receiver, where the microphone is positioned within the hearing aid body to measure acoustic signals from an ambient environment, and where the receiver is positioned within the hearing aid body to emit acoustic signals toward a tympanic membrane of a user; an expandable element, where the expandable element is operatively connected to the hearing aid body, and where the expandable element is configured to encompass a circumferential portion of the hearing aid body when expanded; and an inflation management system, where the inflation management system is configured to expand the expandable element when actuated.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.12/579,673, filed Oct. 15, 2009, which claims the benefit of U.S.provisional patent application No. 61/105,761 filed on 15 Oct. 2008, andclaims the benefit of U.S. provisional patent application No. 61/176,013filed on 6 May 2009. The disclosures of which are both incorporatedherein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to devices and methods for ear waxmitigation, hearing aids, and feedback reduction.

BACKGROUND OF THE INVENTION

Various devices (e.g. headphones, earbuds, behind the ear devices,hearing aids, and other devices that direct acoustic energy into anacoustic measuring device (e.g., ear)) have been designed for varioususes. Many conventional systems have difficulty sealing in the earcanal. Other orifice (e.g., ear, mouth, anus, nose, artery, vein, pipe,indentation) insertion devices additionally have sealing issues. Variousmethods of sealing can impact the orifice walls. The amount of impact isimportant for designing comfortable orifice sealing devices.

With regards to ear devices, many fitting difficulties result from eardimensional changes, for example during chewing. For example somearticles have reported (e.g., ten years of research and developmentsponsored by The National Institute on Deafness and Other CommunicationDisorders (NIDCD) have resulted in a better understanding of ear canaldynamics relative to jaw motion) both contraction or expansion of theear canal volume during jaw motion. It has been reported thatsubstantial numbers of ears have significant shape and size changes withjaw motion, that 51% of subjects have at least one ear canal in whichthe volume expands or contracts at least 10% with jaw opening, that 12%of subjects have at least one ear canal in which the volume contractsmore than 10% with jaw opening, and that only 15% of the population haveboth a symmetric magnitude and direction of volume change in theircanals. Such volume changes cause comfort issues with fitted hearingaids and other devices fitted in the ear canal.

A sample market with associated issues is the hearing aid market. It isestimated that more than 20 million people in the United Statesexperience some form of hearing loss. However, according to the 1990-91National Health Survey, only 18% of those who identified themselves ashaving hearing problems use hearing aids (over the age of three andnon-institutionalized). The reasons people who experience hearing lossbut chose not to use the available technologies include: “hearing aidsdo not perform in noisy situations” (7.1 million), “provide too muchwhistle or feedback” (6.4 million), “do not work well” (4.8 million) or“work only in limited situations” (4.3 million), “have poor soundquality” (3.9 million), “break down too much” (3.4 million), “can not beused on the telephone” (3.1 million), and “negative experiences offriends” (3.9 million) (Kochkin, 1997). Custom hearing aids first use anear mold of the user's ear canal.

Many hearing aids start with a silicon mold of the ear canal, then arescanned and placed into a computer model. The computer model serves asan ear canal. Then a hearing aid is fabricated by trimming the model toform an earmold shell smaller than the ear canal, into which electronicsare placed for a hearing aid. The earmold shell provides several basicfunctions. First, it couples the hearing aid with the user's ear. Itchannels the sound from the hearing aid, through the ear canal, to theeardrum. The earmold shell also helps to secure the electronics of thehearing aid in place. The challenge is to provide the user with a securefit (i.e., a small distance between the earmold shell and the earcanal). Yet the tighter the fit, the more uncomfortable the device is towear. A well-fitted earmold shell directs sound from the hearing aid tothe ear without feedback, thus allowing the user to hear comfortably(Lachapelle, 1999), however the tradeoff is comfort. Earmold shells arerequired for most hearing aids that fit within the ear canal, and sincethe anatomical structure of the ear varies from person to person, themajority (80%) of all earmold shells are custom-made.

Feedback (e.g., between the microphone and receiver) is an issue withhearing aids. Feedback is experienced by 6.4 million hearing aid users.There are two types of acoustic feedback: (1) produced internally fromthe hearing aid, indicating a need for repair; and (2) the more commoncause, externally produced feedback due to leakage of amplified sound,that radiates from the speaker and then is picked up by the microphoneand re-amplified. In many cases, the feedback can be addressed by eitherrepositioning the hearing aid or by reshaping the earmold so that itsfit conforms more closely to the shape of the ear canal (Smedley &Schow, 1998; Sweetow, 1998).

Feedback occurs when the hearing aid does not fit properly and theoutput signal leaks around the earmold, is received by the hearing aidmicrophone, and is amplified. Other causes of feedback include the ventsthat are drilled into them. Vents are used to reduce the “plugged up”feeling experienced when the user speaks. However, the vent alsoprovides an opening for the sound to create feedback within the hearingaid. At high amplification the output signal can again be picked up bythe hearing aid microphone and be amplified. Users who experiencesignificant feedback will adjust the hearing instrument's gain, or willturn it off completely. In the worst-case situation, the hearing aiduser will stop wearing the device altogether.

There is a need to improve the comfort of earmolds while maintaining thesecure fit necessary for proper hearing aid function, including thereduction of acoustic feedback. Chewing, yawning, and other facialmovements change the geometry of the ear canal structure. As theanatomic structure changes, the fit of the earmold is affected causingan increase in acoustic feedback. The hearing instrument may dislodgefrom the ear if the ear canal's shape is changed.

SUMMARY OF THE INVENTION

At least one exemplary embodiment is directed to a method of conforminga hearing aid to fit most users comprising: attaching an expandableelement to a hearing aid body; and attaching an inflation managementsystem to the expandable element, where the expandable element includesan inflatable bladder, and the inflation management system is configuredto provide a medium to the bladder.

At least one exemplary embodiment is directed to a conformal hearing aidcomprising: a hearing aid body, where the hearing aid body houses amicrophone and a receiver, where the microphone is positioned within thehearing aid body to measure acoustic signals from an ambientenvironment, and where the receiver is positioned within the hearing aidbody to emit acoustic signals toward a tympanic membrane of a user; anexpandable element, where the expandable element is operativelyconnected to the hearing aid body, and where the expandable element isconfigured to encompass a circumferential portion of the hearing aidbody when expanded; and an inflation management system, where theinflation management system is configured to expand the expandableelement when actuated.

At least one exemplary embodiment is directed to a method ofdistributing force to increase comfort in a hearing aid comprising:attaching an inflatable system to a hearing aid; and attaching aninflation management system to the hearing aid, where the inflationmanagement system is configured to be actuated, where the inflatablesystem is configured to expand to contact a portion of an ear canal whenthe inflation management system is actuated, and configured so that thepressure of the contact can be adjusted.

At least one exemplary embodiment is directed to a method ofdistributing force to increase comfort in a hearing aid comprising:actuating an inflation management system operatively attached to ahearing aid, where the actuation of the inflation management systeminflates an bladder; and adjusting the pressure in the bladder to auser's comfort.

At least one exemplary embodiment is directed to an adjustable hearingaid comprising: an inflatable system operatively attached to a hearingaid; and an inflation management system operatively attached to thehearing aid, where the inflation management system is configured to beactuated, where the inflatable system is configured to expand to contacta portion of an ear canal when the inflation management system isactuated, and configured so that the pressure of the contact can beadjusted.

At least one exemplary embodiment is directed to a method of hearing aidfabrication comprising: scanning an ear mold and representing the earmold as an ear mold computer simulation; trimming the ear mold computersimulation using software tools to generate a hearing aid simulatedbody; identifying at least one inflation groove on the hearing aidsimulated body using software tools; and generating a modified hearingaid body simulation with the groove.

At least one exemplary embodiment is directed to a method of reducingearwax accumulation in acoustic channels comprising: inserting an offsetvolume from at least one acoustic channel, where the offset volume hasat least one dimension larger than the diameter of the acoustic channel;enclosing the offset volume in an enclosure, where the enclosure has anopening to the at least one acoustic channel; and making at least aportion of the enclosure from a flexible material.

At least one exemplary embodiment is directed to a wax shieldcomprising: a body; a stressed flexible membrane; and where the membraneis attached to the body forming a wax shield, and where the wax shieldis configured to be attached to a device with an acoustic channel, wherethe device is configured to be inserted into an ear canal.

At least one exemplary embodiment is directed to an ear wax mitigationsystem comprising: a hearing aid with an acoustic channel, where one endof the acoustic channel is connected to a transducer and the oppositeend is open; and a pump system, where the pump system is pneumaticallyconnected to the acoustic channel between both ends, and where the pumpsystem is configured to be actuated to force air into the acousticchannel to force loose ear wax out of the open end of the acousticchannel.

At least one exemplary embodiment is directed to an ear wax mitigationsystem comprising: a hearing aid with an acoustic channel, where one endof the acoustic channel is connected to a transducer and the oppositeend is open; and a condensing portion, where the condensing portion isoperatively attached to the hearing aid, where the condensing strip isselected so that cerumen gas condenses on the condensing strip before itcondenses on the material of the hearing aid.

At least one exemplary embodiment is directed to a hearing aid withreduced feedback comprising: a microphone; a receiver; an inflationtube; and an inflation management system, where the microphone isconfigured to measure an ambient environment, where at least a portionof the ambient environment is replayed by the receiver, where theinflation tube is configured to expand to seal a channel the hearing aidis inserted into, where any feedback between the microphone and receiveris reduced as a result of the sealing of the channel by the inflationtube.

At least one exemplary embodiment is directed to a method of reducingprocessor power usage in hearing aids comprising: attaching at least oneinflatable member to a hearing aid circumferentially; and inflating theinflatable member when the hearing aid is inserted into an ear canal,whereby the inflatable member is pressurized to a level where theacoustic path between a speaker and a microphone are reduced resultingin a reduced feedback level compared to an identical hearing aid withoutan inflatable member attached, where the reduced feedback reduces theamount of processor power usage needed for software treatment offeedback.

At least one exemplary embodiment is directed to a reduced power usagehearing aid comprising: an inflatable member operatively attached to ahearing aid circumferentially; and an inflation management system, wherethe inflation management system is configured to be actuated topressurize the inflatable member, where when the inflatable member ispressurized the channel in which the hearing aid is inserted is sealed,where the sealing reduces the acoustic path between a speaker and amicrophone in the hearing aid resulting in a reduced feedback levelcompared to an identical hearing aid without an inflatable memberattached, where the reduced feedback reduces the amount of processorpower usage needed for software treatment of feedback.

At least one exemplary embodiment is directed to a method of increasingthe headroom in hearing aids comprising: attaching at least oneinflatable member to a hearing aid circumferentially; and inflating theinflatable member when the hearing aid is inserted into an ear canal,whereby the inflatable member is pressurized to a level where theacoustic path between a first side of the hearing aid exposed to theambient environment and a second side of the hearing aid inserted into achannel is reduced, where the reduced acoustic path reduces ambientenvironment leakage into the channel, where the reduced leakage reducesthe gain to which a receiver must emit acoustic signals to a tympanicmembrane of a user to achieve the threshold level of hearing for theuser at a 1 kHz signal.

At least one exemplary embodiment is directed to a hearing aid thatincreases the receiver headroom comprising: an inflatable memberoperatively attached to a hearing aid circumferentially; and aninflation management system, where the inflation management system isconfigured to be actuated to pressurize the inflatable member, wherewhen the inflatable member is pressurized when the hearing aid isinserted into an ear canal the acoustic path between a first side of thehearing aid exposed to the ambient environment and a second side of thehearing aid inserted into a channel is reduced, where the reducedacoustic path reduces ambient environment leakage into the channel,where the reduced leakage reduces the gain to which a receiver must emitacoustic signals to a tympanic membrane of a user to achieve thethreshold level of hearing for the user at a 1 kHz signal.

At least one exemplary embodiment is directed to a wax shieldcomprising: a body; a stressed flexible membrane; where the membrane isattached to the body forming a wax shield, and where the wax shield isconfigured to be attached to a device with an acoustic channel, wherethe device is configured to be inserted into an ear canal.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the present invention will become more fullyunderstood from the detailed description and the accompanying drawings,wherein:

FIGS. 1 and 2 illustrate an inflation system in accordance with at leastone exemplary embodiment;

FIGS. 3, 4, and 5 illustrate various cross sections of a catheter inaccordance with at least one exemplary embodiment;

FIG. 6 illustrates the material calculation based upon elongationvalues;

FIG. 7 illustrates an insertion device with at least one inflation tubeto seal a channel that the insertion device is inserted in accordancewith at least one exemplary embodiment;

FIG. 8 illustrates an insertion device with at least one inflation tubeto seal a channel that the insertion device is inserted in accordancewith at least one exemplary embodiment;

FIGS. 9A-9L illustrate a method for designing a hearing aid configuredto accommodate an inflation tube;

FIG. 10 illustrates the effect of insertion depth on insertion loss fora first commercial product versus an inflation system in accordance withat least one exemplary embodiment;

FIG. 11 illustrates the effect of insertion depth on insertion loss fora second commercial product versus an inflation system in accordancewith at least one exemplary embodiment;

FIG. 12 illustrates a wax shield in accordance with at least oneexemplary embodiment;

FIG. 13 illustrates the attachment of a wax shield to an acoustic devicein accordance with at least one exemplary embodiment;

FIG. 14 illustrates a method of stressing a membrane before attachmentto a wax shield in accordance with at least one exemplary embodiment;

FIG. 15 illustrates acoustic transparency of a wax shield in accordancewith the stressed state of a membrane built into a wax shield;

FIG. 16 illustrates acoustic transparency of various materials;

FIG. 17 illustrates acoustic transparency of various stressed materials;

FIG. 18 illustrates acoustic transparency of various stressed materials;

FIG. 19 illustrates acoustic transparency of various stressed materials;

FIGS. 20-23 illustrate an earpiece in accordance with at least oneexemplary embodiment;

FIG. 24 illustrates at least one exemplary embodiment using a forcedpressure to remove earwax from the acoustic channel;

FIG. 25 illustrates at least one exemplary embodiment using an offsetfilament to keep earwax from the acoustic channel;

FIG. 26 illustrates at least one exemplary embodiment using a forcedpressure to remove earwax from the acoustic channel; and

FIG. 27 illustrates at least one exemplary embodiment using a condensingstrip to condense earwax out of the environment onto the strip.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE PRESENT INVENTION

The following description of exemplary embodiment(s) is merelyillustrative in nature and is in no way intended to limit the invention,its application, or uses.

A multitude of materials can be used for exemplary embodiments, and theuse of material depends upon the use the exemplary embodiment is to beused. For example a wax shield can have a lower permeability value tocerumen, but a higher permeability to air, whereas an inflation systemcan have a lower permeability to air than the wax shield. Additionallythe permeability used as a design factor is dependent upon theobjective. For example if a level of pressure loss in an inflationsystem is allowable over a period of time, an acceptable permeabilitycan be determined and a material for the inflation system chosen basedupon permeability. Additionally the form function of the balloon in theinflated state and the uninflated state can determine the elongationvalue needed. The elongation value can be used to further refine thematerial that can be used for the inflation system. For example somematerial that can satisfy permeability if the goal is to lose a few % ofatm in a few hours is Polystyrene, Polyethylene, Nylon 6, Polyethyleneterephthalate, Teflon™, and Evoprene™. Then selection can be made basedupon elongation, for example expanding from an initial 3 mm InnerDiameter (ID1) expanding to a tube 10 mm expanded Inner Diameter (ID2),which results in a linear elongation of [2*pi*(5 mm)]/[2*pi*(1.5 mm)] ofabout 333%. Note that a further determination can be made based upon thehysteresis of a material of the stress strain curve. Thus a material canbe chosen that has a hysteresis curve that is less during theoperational ranges of temperature, and elongation %.

Exemplary embodiments are directed to or can be operatively used onvarious wired or wireless devices (e.g., earbuds, headphones, earterminals, behind the ear devices or other acoustic devices as known byone of ordinary skill, and equivalents) or other devices that can bepart of a user interface or inserted into an orifice (e.g., ear canal,nose, artery, vein, cavity, recess, anus, throat, pipe, chamber).

Processes, techniques, apparatus, and materials as known by one ofordinary skill in the art may not be discussed in detail but areintended to be part of the enabling description where appropriate. Forexample specific materials may not be listed for achieving each of thetargeted properties discussed, however one of ordinary skill would beable, without undo experimentation, to determine the materials neededgiven the enabling disclosure herein.

Additionally exemplary embodiments are not limited to ear devices, forexample some functionality can be implemented on other systems withspeakers and/or microphones for example computer systems, PDAs,BlackBerry® smart phones, cell and mobile phones, and any other devicethat emits or measures acoustic energy but also for common items such ascups, utensils, medical inserts and devices, and pipe inserts.Additionally, exemplary embodiments can be used with digital andnon-digital acoustic systems. Additionally various receivers andmicrophones can be used, for example MEMS transducers, diaphragmtransducers, for example Knowles' FG and EG series transducers.

Notice that similar reference numerals and letters refer to similaritems in the following figures, and thus once an item is defined in onefigure, it may not be discussed or further defined in the followingfigures.

Additionally any inflatable system can include fluid (gas or liquid) aswell as include a soft, flexible/expandable section to manage mandibularmovement. A soft expandable medium can be used to maintain contact withthe ear canal wall when the jaw moves (mandibular movement). For examplea heat expansive material, light expandable, or other materials thatwould maintain a comfortable level of pressure, for example one thatexpands about 1 mm beyond the not stretch ear canal wall.

The fillable material referred to herein can be viscous and can includesilicone, non or low permeable-based polymers, gels, vinyl elastomers,or any other material of sufficient properties to allow the deformationof a membrane cavity from user contact. Materials can also be used toprovide a slow reformation of the original membrane cavity shape afterit has been deformed and released. In this regard, a silicone, non orlow permeable gel or other non-cross-linked polymer or uncatalyzedmaterials may be used. It should be appreciated that the composition ofthe fillable material could be altered for applications in which variedmembrane characteristics are desired (i.e. more stiffness, durability,more or less deformability and/or longer-lasting deformation). Thefillable material may be elastically deformed or it may be deformed bydisplacement, which is the actual movement or flow of the fillablematerial in response to pressure, such as that from a user's fingertips.In addition, the fillable material could be altered for applications inwhich varied temperature or light conditions would be encountered duringthe use of particular products on which the membrane cavity is mounted.

The portion of a membrane (e.g., used for the flexible membrane)connected to a structure (base membrane) can be made of any material,rigid or elastic, including various plastic or metal materials, or itcan be made of a membrane formed of thin rubber-based material,deformable plastic or silicone, non or low permeable-based materials orother elastomeric materials suitable for a given application. Note alsovarious low permeable (to the filler medium, such as air) flexiblemedium can be used for balloon material. The permeability can be definedsuch that a pressure of 0.1 bar gauge can leak from the balloon in 8hours. Note the pressure value can change and the time value can change.For example the pressure value can be 0.01 bar in 16 hours.

If the base is configured as a flexible membrane, the cavity can moreeasily conform to a product's surface, thereby increasing the ease withwhich the cavity can be installed, removed, and replaced. Likewise, theouter membrane also can be made of a thin rubber-based material,deformable plastic, low permeability materials, Teflon materials,silicone, non or low permeable polymer materials, or other elastomericmaterials suitable for a given application. If the base membrane andouter membrane are made of silicone, non or low permeable material, bothshould be from 0.50 mm to 2.5 mm in thickness. In this regard, the basemay be a membrane instead of a piece of rigid material. The edges of theouter membrane and the base membrane can be mechanically fastened orclamped forming the membrane cavity. Additionally, at least a portion ofthe base membrane can be adhesively attached (e.g., adhesive tape, glue)or mechanically fastened to the support structure.

In at least one exemplary embodiment a silicone cushion can be used incomponents that contact the skin, where a membrane contains a siliconefiling. The silicone, non or low permeable sealant can be of an acetoxycure type. In particular, upon exposure to moisture, the silicone, nonor low permeable sealant will give off small amounts of acetic acidwhile the sealant cures. It is not recommended that the acetic acidvapors be inhaled. The sealant will cure in 24 hours and has a tack freetime of 10-20 minutes at 77.degree. F. (25.degree. C.) with 50% relativehumidity. The sealant's tensile strength is approximately 350 psi, itselongation property is 450%, and its hardness is approximately 25-30Shore A. The sealant has temperature stability from −85.degree. F. to450.degree. F. (−65.degree. C. to 232.degree. C.) and can withstandintermittent exposure to temperatures as high as 500.degree. F.(280.degree. C.). The sealant is believed to have good resistance tovarious weathering conditions, including UV radiation, rain, snow, etc,without hardening, cracking, or shrinking.

For optimum adhesion with the above adhesive, the support structure andthe lower surface of the base membrane should be clean, dry, and freefrom oil, grease or other foreign material. If necessary, metal surfacesshould be wiped with a non-oily solvent. Rubber surfaces should beabraded to promote adhesion. Depending on environmental conditions, thebase and product surface should be joined within 5-10 minutes, beforethe tack-free time of the sealant passes.

An earpiece system can include a sealing section. At least one exemplaryembodiment of the sealing section can be made disposable forperformance, hygienic, and utility reasons. To minimize cerumen buildup, it can be removed as much as possible before it builds up in areasof the ear canal or in the acoustic channels. This is achieved byremoving cerumen while it is in a vapor stage (in the air). The sealingsection of the earpiece can include material for absorbing cerumenthereby preventing buildup. In at least one exemplary embodiment, thesealing section is a balloon filled with a gas, liquid, or gel. In thisparticular exemplary embodiment the balloon material is designed toattract and absorb the cerumen in vapor form. Moreover, in at least oneexemplary embodiment the material can prevent the cerumen from oxidizingby absorbing oxygen into the membrane or by allowing oxygen to enter theballoon but not cerumen, thus decreasing the amount of oxygen in the earcanal. Cerumen turns yellow when in contact with oxygen over an extendedperiod of time. Non-oxidized cerumen is clear thus keeping it in thetransparent state will be less noticeable on the sealing section of theearpiece when it is from the ear. In one embodiment, the material wouldbe of one or more parts or layers, such that the low-viscosity, flowingcerumen type from the apocrine glands is trapped, and such that thehigh-viscosity, waxy cerumen type from the sebaceous glands is trapped,precluding either from migrating down the sound tube into the receiverelectronics. The material can be located in any of the followinglocations, or combination thereof: over the tip of the sound port, alongany portion of the inside wall of the sound port, along the exteriorwall of the insertable eartip. The mechanism for trapping either or bothvarieties of cerumen may be any of the following: 1) to collect andharbor the cerumen on the surface of the material; 2) to act as apermeable membrane with porosity to trap the cerumen within itsstructure, 3) to act as a mesh filter to allow certain substances ofsufficiently small unit size to flow through, but to block othersubstances of larger unit size (such as cerumen) by trapping it in thefabric of the mesh. The cerumen trap material provides its function viaits own reaction, and thus change of state, upon insertion or soonthereafter to one of more of the ambient conditions within the earcanal, inclusive of high humidity, temperature that is near to the bodycore temperature (approx 98.6 degrees F.), or TMJ movement. The materialhas a chemical and/or structural composition that exhibits an affinityfor one or both types of cerumen. The sealing section can be replacedperiodically to maintain hygiene and performance of the system. Thematerial can be attached to the earpiece via adhesive bond,friction-fit, interlocking means, elastic means, and/or as an integralpart of the earpiece that is molded into the structural material of theearpiece. Periodic replacement is one method of maintaining a cleanacoustic channel. Notification is provided for the end-user to know whenthe cerumen trap should be replaced, there is provision for the materialto change color, shade, or other obvious visual attribute. The materialcan be affixed to the earpiece, such that it can be replaced by anend-user with no special tools or chemicals. Reducing concentration ofcerumen in the ear canal area.

The gas in the ear canal when sealed by the earpiece will increase inconcentration of cerumen as the body excretes the material. The cerumeneventually reaches a level of concentration where it comes out of thevapor and forms a solid in the ear canal. Circulating air into and outof the ear canal can minimize the build up of solid cerumen by reducingthe vapor concentration of cerumen when replaced with gas having nocerumen. Air from the ambient can be brought into the ear canalperiodically. Alternately, gas from a system for increasing/decreasingpressure in a balloon can be ported to the ear canal and a path providedout of the ear canal opened to remove gas from the ear canal therebyreducing the concentration of vaporous cerumen. Thus a material that ispermeable to cerumen gas but not to or less than air can be used toallow the escape of cerumen, mimicking an open ear.

In at least one exemplary embodiment the sealing section of the earpiececan comprise an electrolysis unit for generating gas to pressurize asealing balloon. Similarly, a manual pump can be implemented to pump upthe balloon to seal the ear canal. Gas from the pressurized balloon,manual pumping, or a separate pressurized cleaning bladder can be usedto blow out debris in the acoustic channels. In a cerumen cleaningprocess, a valve can be opened to the acoustic channels coupled to apressurized source of gas. The force generated by the pressurized gastraversing the acoustic channel will move the debris from the openingclearing the channel. The process can be controlled by a microprocessorof the system.

In at least one exemplary embodiment a voltage/current controlledpolymer can be used to cover the opening of the acoustic channels whenthe microphone or the receiver is not being used. The cover preventsdebris from accumulating in the acoustic channel when the device is notbeing used. A control signal provided by the process opens the coverwhen either the microphone or receiver is being used.

The cover can have small opening for allowing acoustic signals to passinto the acoustic channel at all times under conditions of low activity.A pressurized gas can be used to clear the openings. The cover can beopened exposing the acoustic ports to ensure coupling to the ear canalunder control of the microprocessor. The material mounted over the soundport, can be of either an impervious (imperforate) membrane which willpreclude any passage of earwax but will be excited by incident soundwaves and pass them, in the same manner as a drum head, or a porousmembrane whose passages are smaller than the smallest unit of cerumen sothat the cerumen will be held in the membrane, but which allows airmolecules to pass through, thus passing sound wave energy. The former(impervious membrane) solution will also preclude the passage of earcanal perspiration and other liquids. The cover can also be a trap forthe cerumen to be contained in the cover. The cover does not pass soundin this example and is opened to expose the acoustic channel when theearpiece is operational.

In at least one exemplary embodiment a voltage/current controlledpolymer can be used to clean debris from the acoustic channel. Thepolymer can be designed to physically move from one position to anotherposition. For example, the polymer can reside in the acoustic channel inone state and extend out of the acoustic channel in a second statethereby pushing debris out of the tube. The polymer can sweep the portsof the acoustic channel similar to a windshield wiper. The polymer in afirst state resides on one side of the stent port and sweeps across theopenings to a second side of the stent ports. The polymer can bedesigned to create a sweeping motion internal to the acoustic channelwhere multiple polymer fingers are used in sequence to make the sweepingmotion moving debris from internal to the channel towards the port andthen out of the port.

In at least one exemplary embodiment protrusions on the stent throughwhich the acoustic channels travel to create areas away from the portsas collection points for cerumen. For example, multiple protrusions atthe tip where the ports are located. Cerumen is likely to be collectedon these extensions. The extensions do not affect receiving or providingan acoustic signal. Forced gas through the acoustic tube can clean offthe extensions. Tip or port shape of the acoustic channel can impact howthe gas is concentrated to remove debris.

At least one exemplary embodiment is directed to at least one of: 1.) apressurized sealing section that blows out debris in or around anacoustic channel; 2.) electrolysis to generate a gas; 3.) a manual pumpto inflate a sealing section, a restoring force balloon, an extrareservoir for cleaning; 4.) an elastic or inelastic balloon; 5.) acurrent/voltage controlled polymer; 6.) an acoustic channel cover; 7.) apolymer acoustic channel cleaner (sweeping movement inside tubes); 8.) aperforated cover to let sound in; 9.) valving to blow out an acousticchannel; 10.) detection methodology of a blockage possible using a highfrequency signal (could go to a frequency above human hearing if atransducer will allow); 11.) a material of a balloon or somewhere on theearpiece that attracts or is permeable to cerumen (can be a one waymembrane); or 12.) if a balloon is liquid filled it could contain asubstance that dissolves cerumen, is antibacterial, and lubricates theear canal wall such as a cyclodextrin.

Note that there are several advantages of the inflation system. 1.) TheIMS (inflation management system) mitigates repeated need to take newimpressions for poor fitting. The same is true for weight loss (change)of the wearer. One size fits many. 2.) Utilizing an inflated membranearound the circumference or down path around a partial or whole assembly(except where the sound would emanate out of) would reduce significantlythe need for adaptive feedback control (AFC). 3.) An IMS can enhancecomfort. 4.) An IMS can be used for stability in the ear, thus thereduction of loss of instruments as the ear is moved. 5.) The IMS hasbeen tested and reduces the occlusion effect. 6.) An IMS can producebetter comfort, stability, and acoustical satisfaction, which governsoverall enhancement of user compliancy. 7.) An IMS can reduce totalpower of the processor since AFC has been reduced. This can extendbattery life. 8.) Increase in available gain before feedback sets in,improving the voice intelligibility for the wearer. As well, improvingthe ambient field so the wearer has better situation awareness. 9.)Reduction of possible trauma during head inquiry from balloon“absorbing” shock and impact rather than the hearing aid migrating downthe acoustical pathway. 10.) If used with an ECM, a more natural voiceof a listener due to reductions of the occlusion effect. If broadcastedto others, a more natural voice to the receipt. 11.) Increase of speechintelligibility based on reduction of voice resonance.

Exemplary Embodiments

Note that many of the sizes of the devices can vary so that a device canbe about multiple mm in diameters, and multiple mm in length, with amass varying from 0.5 gram to hundreds of grams. For example sealingsections (e.g., hoop balloons used for the circumference in hearing aidfabrication) can be in the minimal compressed dimension to the hearingaid dimension (e.g., 8 mm diameter) and an expanded dimension (e.g., 14mm) needed to seal the hearing aid.

Exemplary embodiments of the present invention will become more fullyunderstood from the detailed description and the accompanying drawings,wherein:

FIGS. 1 and 2 illustrate multiple balloons in at least one inflationsystem in accordance with at least one exemplary embodiment. Theexemplary embodiment of the inflation system illustrated can include acatheter 200 of length L1 (e.g., 10-40 mm), and outside diameter OD. Inthe particular non-limiting example illustrated a balloon (e.g.,multi-chamber) can be attached to the catheter (e.g., bonded, adhered,glued, thermal bonded, molded, ultrasonic bonding). The balloon can beinflated via inflation holes 100 to inflate separate multi-chambers ofthe balloon. The balloons can be inflated separately or simultaneously.The balloon can expand to an outer radii L5 (e.g., 3-8 mm), with anaxial extent along the axis per chamber, L6 (e.g., 1-15 mm), with thechambers separated by a gap of L2 with midline separations of L3 (e.g.,1-20 mm). Where the thickness of the balloon dt can be varied (e.g.,0.005-2.0 mm). Note that the balloon can be made of various materials.For example a balloon can be made of a material that has lowpermeability to the medium that is within the balloon. For example ifthe medium in the balloon is air, and the design criteria is that theballoon retains pressure for a period of time, such design criteria willguide which flexible material to use. For example some material that cansatisfy permeability if the goal is to lose a few % A) of atm in a fewhours is Polystyrene, Polyethylene, Nylon 6, Polyethylene terephthalate,Teflon™, and Evoprene™.

FIGS. 3, 4, and 5 illustrate various cross sections of a catheter/stentin accordance with at least one exemplary embodiment. Note that thecatheter/stents can be made of the same material as the balloons. Thecatheters (e.g., 400, 500) are attached to the single or multipleballoons 410, where multiple channels (e.g., 330, 510, 520) can beembedded in the catheter 500. The multiple channels can be chosen sothat each channel can inflate a separate balloon to different pressures.For example pressures can be chosen for comfort levels and/or soundisolation levels. For example gauge pressure values inside the balloonscan be between 0.001 bar and 2.0 bar. The multiple channels can be usedas various use channels, for example acoustic channels or pneumaticchannels. Note that the catheter 500 can be flexible along its long axisso that it can bend around several corners (e.g., traversing an earcanal) but be firm enough to facilitate insertion (e.g., Shore Durometer30-70).

FIG. 6 illustrates the material calculation based upon elongation valuesfor another exemplary embodiment of an inflation system 600. Dependingupon the elongation % of the material an extra amount of material 610can be used to facilitate the reduction of permanent deformation of themultiple chambers (e.g., 620, 630) of the balloon. A simple linearelongation % calculation is illustrated and can be used to calculate arough extent of any extra material needed (L0 minus bonding distance).The linear calculation is a non-limiting example and more detailedanalysis can be used to determine an ideal length. For example an areaand volume of the material can be used, and the critical elongationbefore permanent deformation occurs can be used to design the L0 value.

FIG. 7 illustrates an insertion device 700 with at least one inflationtube (e.g., 740, 750) to seal a channel (e.g., 730) that the insertiondevice is inserted in accordance with at least one exemplary embodiment.As illustrated a body 770 can have grooves for inflation tube inserts.An optional wax shield 710 can be operatively attached (glued, bonded,thermal bonded, ultrasonic bonding, molded) to the body 770. The waxshield 710 can have a portion 720 that is a flexible membrane that isacoustically transparent (for example the acoustic energy 780A to 780B,via acoustic port 760). The flexible membrane 720 can be a material thathas a low permeability to cerumen gas and is acoustically transparent.Although it can be impermeable to cerumen gas and then stressed to adesign % to facilitate acoustic transparency but serve as a shield toprevent cerumen gas from entering the acoustic channel.

FIG. 8 illustrates an insertion device 800 with at least one inflationtube (e.g., 820, 830) to seal (e.g., reduction of acoustic energy 880 toenergy 890 to energy 870) a channel (e.g., 810) that the insertiondevice 800 is inserted in accordance with at least one exemplaryembodiment. In this non-limiting example one side of the insertiondevice 800 can be partially acoustically isolated from the oppositeside. For example the insertion body 840 can have one side in an earcanal where a receiver emits acoustic energy toward the ear canal, wherethe receiver (e.g., due to the inflation tubes 820, 830) can beacoustically isolated by a microphone on the side of the insertiondevice 800 on the ear aperture side of the insertion device 800. Suchacoustic isolation aids the reduction of feedback between the microphoneand the receiver, for example in a hearing aid. For example an acousticsignal from the aperture side (proximate to energy 880) can beacoustically reduced to energy 890 and to energy 870, while passing theinflation tubes 820 and 830 which press against the channel 810, atpositions 850 and 860 respectively.

FIGS. 9A-9H illustrate a method for designing a hearing aid configuredto accommodate an inflation tube. Note that any type of hearing aid(e.g., Completely In Canal, CIC) can use methods of exemplaryembodiments. FIG. 9A illustrates an ear mold 900, which can be 3-Dscanned and placed into a computer model as a virtual representation 910of the ear mold (FIG. 9B). The ear mold can be via a silicon impressionmaterial or optically scanned. The virtual representation 910 can befurther reduced using software tools (e.g., a person (e.g., designer)can utilize a mouse to click on portions of the virtual representation910 in a software CAD system) to create a reduced version 920 (FIG. 9C)inside the virtual representation 910, where the virtual representationcan be used as a virtual ear canal. For example a software tool can beconstructed so that a given distance normal to the virtualrepresentation can be constructed forming the reduced version 920.

The reduced version 920 can form the basis of a body of an earpiece suchas a hearing aid. A designer can select (e.g., via clicking the buttonon a mouse) portions of the reduced version 920 that are further removedto accommodate further structures (e.g., male connecting portion 930 toa wax shield 940 (FIG. 9E), acoustic channels 931 to a receiver 932) ina modified version 925 (FIG. 9D). The designer can further selectinflation grooves (e.g., 950, 960) and support inflation channels (e.g.,970), which can then be removed (e.g., manually indicating the sectionto remove or programmed to remove a set amount for standardizedinflation tubes) (e.g., grooves removed 955, 965 and 975 from thecomputer model) from the modified version 925 forming a grooved model927. The grooved model 927 can then be fabricated (e.g., molded, CNC,SLA) to form the body of the hearing aid and inflation tubes andinflation lines attached onto the body of the hearing aid. Then apumping mechanism 987 (e.g., manual, electrolysis) can be attached tothe inflation tubes 957, 967 and 977.

FIGS. 9I through 9K illustrate several versions of earpieces that canuse the inflation management system whose fabrication is illustrated inFIGS. 9A-9H. In addition to a receiver (i.e., a speaker) 932 (coupled toacoustic channel 933), a microphone 951 (coupled to acoustic channel937) can be included. Both the receiver 932 and the microphone 951 canbe operatively attached to a circuit 941. The circuit 941 can include aprocessor chip or can be a circuit that is configured to modify (e.g.,amplify) the acoustic signal measured by the microphone 951 and emit themodified acoustic signal from the receiver 932. For example themicrophone 951 can pick up the ambient environment and emit it via thereceiver 932 amplified, enhancing a user's hearing. Note that manymicrophones and receivers can be used herein in the exemplaryembodiments described (e.g., Knowles TWFK receivers, FG microphones) andthe discussion herein is not meant to limit which microphone or receiveris used in the exemplary embodiments.

FIG. 9J illustrates the use of a microphone 952 to pick up acousticsignals from the same region that receiver 932 emits them. For examplean earpiece can be configured to use a microphone 952 to pick up voicethrough the head, and operatively connected to a circuit 941, transmitthe picked up voice remotely. An inflation system can enhance thequality of the voice pickup by reducing the occlusion effect, resultingin a clearer voice quality (e.g., one with reduced resonance in theclosed region near the ear drum).

FIG. 9K illustrates the use of two microphones (e.g., microphones 952and 951), where one microphone (951) monitors the ambient environmentand the second microphone (952) the environment in the ear. Such aconfiguration can be used for communication in noisy environments, wherethe inflation system provides mitigation of the occlusion effect,enhancing voice pickup by microphone 952, which can then be sent viacommunication pathways (e.g., CDMA, RF) to another party. In a low noiseenvironment the voice pickup by microphone 951 can be sent. Note thatcircuit 941 can be a DSP chip, a simple circuit board with preamps, orother earpiece related circuit that can modify any received acousticsignal.

FIG. 9L illustrates an example of a shell 971 that can be CAD reducedfrom virtual representation 910. The shell can contain the contents of ahearing aid. The shell can be sent to an SLA machine for fabrication orother manufacturing system that can generate the shell from the CADdrawing.

FIGS. 10 and 11 illustrate the effect of insertion depth on insertionloss for a commercial product versus an inflation system in accordancewith at least one exemplary embodiment. As illustrated a commercialhearing protection device's effectiveness is strongly determinant uponthe insertion depth. Many devices (e.g., foam plugs) are not insertedpast the 2^(nd) bend of an ear canal. One advantage of the inflationmanagement system (IMS, balloon, catheter) in accordance with at leastone exemplary embodiment is that insertion effectiveness and depth canbe repeated consistently. For example FIG. 11 illustrates a commercialfoam plug (Commercial Product 2), compared to an inflation managementsystem (IMS) type 1, note the much smaller spread as a function offrequency of the IMS system as a function of insertion depth comparedwith the commercial product. Thus the IMS system performs moreconsistently than the commercial product tested.

FIG. 12 illustrates a cut away of a wax shield 1200 in accordance withat least one exemplary embodiment. A catheter 1240 with channels 1230(e.g. acoustic channel) is illustrated. In some circumstances when thecatheter 1240 is placed in an environment (ear canal) a medium (e.g.,earwax) in the environment can clog the channel 1230. To avoid themedium from entering and clogging the channel 1230 a shield (e.g.,waxshield) can be attached to the end of the catheter 1240. Thewaxshield can include a body 1220 and a membrane portion 1210. Ifacoustic signals are played from the acoustic channel 1230, they can bedamped by the membrane portion 1210. The acoustic transparency of themembrane can be modified based upon material, thickness, and stress ofthe membrane. In at least one exemplary embodiment the membrane is madeto have a low permeability to ear wax both in its liquid, solid, andgaseous form. In at least one exemplary embodiment there is an offsetdistance between the membrane and the end of the catheter. In at leastone exemplary embodiment the diameter of the membrane is larger than thecross sectional diameter of the channel 1230. The waxshield can beoperatively attached to the catheter 1240 (e.g., bonded, molded, glued,adhered, thermal bonded, ultrasonic welded). In at least one exemplaryembodiment the waxshield is stressed to a design elongation, where theelongation is chosen to maximize acoustic transmission through themembrane. For example a highly stressed membrane (e.g., 100% or more) isless acoustically transparent, but if the same membrane is stressed to alower amount (e.g. non-zero, 20-70%) the membrane can become moreacoustically transparent than even a non stressed membrane. Note thatthe membrane can be fabricated from materials similar to the balloons,or even air permeable materials like silicon, or rubber.

FIG. 13 illustrates the attachment of the waxshield to an acousticdevice in accordance with at least one exemplary embodiment. In theexemplary embodiment illustrated a stop 1325 is built into the waxshieldso that an offset volume of V1 is created when the waxshield isattached. A catheter 1300 having an acoustic channel 1340 can beattached (A) to the waxshield, for example via bonding (e.g., glue,adhesive, UV cured, molded together). The waxshield can have a sleeve1310, a stop 1325, and a stressed membrane 1320.

Note that in at least one exemplary embodiment the stressed membrane isplaced directly over the port of the acoustic channel 1340, without anoffset volume V1.

FIG. 14 illustrates a method of stressing a membrane 1320 beforeattachment to a waxshield in accordance with at least one exemplaryembodiment. For example an initial membrane 1400 can be elongated 1410prior to attachment to the waxshield body. The optimum elongation % isdependent on membrane material, membrane unstressed thickness, and areaextent. Note that for a given thickness the flexibility of the membraneor the ability to propagate acoustical signals can vary as the stress isincreased since as the membrane is stressed the thickness decreases.Thus if the thickness effects are larger than the damping effect due tomembrane stress, the membrane can be more flexible and transmitacoustical signals better than when unstressed. One can calculate theelongation amount by several methods of which at least one will beexplained. The unstressed membrane has a volume V. An area A then givesa thickness of t=V/A. If the membrane is stressed (e.g., area Aincreased to A1 where A1>A) then the new thickness t1 is t1=V/A1. The %of strain increase (referred here as elongation) can be expressed as thechange in a dimension (e.g., length, thickness), area change (e.g.,A1/A), and volume change in the effective region (the areal portion usedacross an acoustic port, e.g., the area covering 1320). The strain(change in area, length, volume) and/or stress (force/area perpendicularto force) can be related to acoustic transparency. FIGS. 15-19illustrate the various levels of acoustic transparency as a function ofelongation versus material, where in these non-limiting examples theelongation % is a linear variation. For example if the initial length is10 mm then stretching of the membrane in one dimension to 12 mmconstitutes an elongation % of 20%, thus as plotted in FIG. 19 wouldrelate to an X=20 value.

FIG. 15 illustrates acoustic transparency of a waxshield in accordancewith the stressed state of a membrane built into a waxshield. Note thatfeatures in the initial acoustic source 1510 are repeated in some of thestressed membrane plots (e.g., 1560). What is illustrated in FIG. 15 asthe initial acoustic source 1510 is the spectrum of the initial sourceas measured by a microphone at a given location without a membrane inplace. Then various membranes that have been stressed to various valuesare inserted between the source signal (e.g., receiver) and themeasuring microphone. 1540 illustrates the spectrum passing anunstressed membrane. Note that an unstressed membrane 1540 can have alarger gap (i.e. decreased intensity as a function of frequency) betweenthe source 1510 than a stressed membrane 1530, thus some of the featuresin the initial acoustic source 1510 have been removed (e.g., 1560).Larger stresses can decrease the acoustic transport through themembrane, for example a larger stress 1550 rigidizes the membrane makingthe membrane acoustically reflective. Thus 1520 the gap between thesource and the sound making it through a stressed membrane is firstreduced as the stress increases (e.g., via thinning the membrane whilenot appreciably restricting the motion of the membrane). Thus a waxshield membrane 1200 can be placed above an acoustic port. There canalso be an offset distance between the acoustic port. This allows themembrane area to be larger than the acoustic port exit area and thusfacilitates acoustic sensitivity by allowing the membrane surface tovibrate more freely if the acoustic exit area is small. For examplesince the vibration stroke of the membrane communicates acousticpressure a smaller confined area limits the modes of vibration'samplitudes, effecting the amplitude that can be communicated as afunction of frequency.

FIG. 16 illustrates acoustic transparency of various unstressedmaterials (1610, 1620, 1630, 1640, and 1650) that can be used for themembrane in the waxshield. The material showing little deviation from1600 (the unstressed acoustic source) is the material with the bestacoustical transparency.

FIG. 17 illustrates acoustic transparency of various stressed materialsthat can be used for the membrane in the waxshield. FIG. 17 illustratesthe same material as illustrated in FIG. 16 for a particular elongation% (X). FIG. 17 illustrates a method of choosing between a series ofmaterials, by choosing the material whose frequency spectrum is closestto the source signal. For example one can choose the spectrum with bestleast squares fit to the source signal.

FIG. 18 illustrates acoustic transparency of one material at variousstresses for a closed cavity experiment, illustrating that variousstresses can be acoustically more transparent than other stress values.Note that the stress can have an elongation value from 0% up to 2000%.As clearly illustrated various levels of elongation have higher valuesof acoustic transmission than an unstressed state. Thus once a materialis selected, FIG. 18 illustrates a method of choosing the optimum stressfor the material. For example an elongation X % would be chosen over(100+X) % since an elongation of X % provides more acoustical energytransmission than in the unstressed state or (100+X) % state.

FIG. 19 illustrates acoustic transparency of one material at variousstresses for an open cavity experiment, illustrating that variousstresses can be acoustically more transparent than other stress values.Note that the stress can have an elongation value from 0% up to 2000%.As clearly illustrated various levels of elongation have higher valuesof acoustic transmission than an unstressed state. Thus once a materialis selected, FIG. 19 illustrates a method of choosing the optimum stressfor the material. For example an elongation X % would be chosen over(100+X) % since an elongation of X % provides more acoustical energytransmission than in the unstressed state or (100+X) % state.

FIGS. 20-23 illustrate non-limiting examples of earpieces 2000 inaccordance with at least one exemplary embodiment. As illustrated, ahousing 2050 (e.g., housing electrical components such as Knowles FG, TOmicrophones 2110 and TWFK receivers 2120 (for example coupled to circuitboard 2140)), can be operatively connected to a grip 2040 whichinterfaces, for example via body portion 2030, the electrical componentsto a multilumen stent 2010 that can have multiple acoustic channels(e.g., 2220 and 2230). The stent 2010 can have attached an inflatableelement 2020. Note that an additional ambient environment microphone2130 (e.g., a MEMS microphone) can monitor the ambient environment. Notethat the inflatable element 2020 can be inflated via an inflation port2210 connected to one of the multilumens that can be sealed at one endand connected to a pump system at the other to inflate the inflatableelement 2020. FIG. 23 illustrates another exemplary embodiment, where anelastic membrane 2310 can provide a restoring force B2, which causesexpansion B1 of the inflatable element. When the inflatable element iscompressed A1 then the elastic membrane is expanded A2. The earpiecesillustrated in FIGS. 20-23 can have wax shields at the end of the stent2010 as described previously. FIGS. 24-27 illustrate furthernon-limiting examples of ear wax mitigation. In general FIGS. 24 and 26illustrate a forced air method of clearing the acoustic channels, FIG.25 illustrates filaments to keep ear wax away from acoustic channels,and FIG. 27 illustrates a condensing strip to condense the ear wax at acontrolled location away from the acoustic ports.

FIGS. 24 and 26 illustrate a forced air method of clearing acousticchannels. For example a user controlled push button bladder can beconnected to an earpiece so that forced air 2460 travels down apneumatic channel which can be made a one way flow via one-way pressurevalves (e.g., 2450, 2450A, 2450B, 2450C, and 2450D). Thus the pressureof the forced flow 2460 can push air through acoustic channels 2430 and2440, which can be respectively coupled to transducers 2410 and 2420.Ear wax 2470 that has entered one of the acoustic channels (e.g., 2430)can be removed 2490 via the forced air. FIG. 26 illustrates aconfiguration where two one way valves (e.g., 2450C and 2450D) allow abuilt up of pressure in the acoustic channels (e.g., 2430 and 2440)forcing the ear wax 2470 from the obstructed channel when the pressurebuilds up to the point where the force on the ear wax 2470 is such todislodge it from the acoustic channel (e.g., 2430). Note that 2400 canbe a stent with the multilumen channels acting as acoustic channels 2430and 2440. Note the valves 2450, 2450A, 2450B, 2450C, and 2450D can bedifferent types of valves, for example 2450, 2450C and 2450D can beduckbill valves, while 2450A and 2450B can be unique membrane one wayvalves.

FIG. 25 illustrates a multilumen stent 2500, where two of the lumens areacoustic channels 2430 and 2440. Optional one way valves (e.g., 2450A,2450B) can be added to reduce ear wax from entering any of the acousticchannels. This method is independent of filaments 2580. Valves 2450A and2450B can be very thin membrane valves that essentially allow a pressurewave to pass the valve in essentially one direction. For example a oneway membrane acoustic valve can be a membrane composed of tiny (e.g., <1mm OD) conical structures with openings that are closed with no pressuredifference between the sides of the cone. Upon impingement of the backof a cone the pressure forces open the flexible cone allowing thepressure to pass through, whereas a similar pressure incident on thepoint side of the cone forces the closing of the opening reflecting alarge portion (e.g., >50%) of the acoustic energy). The filaments 2580can be used independent of any valves in at least one exemplaryembodiment and can be composed of any material that will offset earwax2470 away from the acoustic channel opening (e.g., Teflon, silicon, lowdurometer plastics and polymers).

FIG. 27 illustrates at least one further ear wax mitigation device 2700in accordance with at least one exemplary embodiment. The device 2700can include in general an inflation element 2730, a low ear wax gascondensing portion 2720 (e.g., stent, portion of tip) and a larger earwax condensing portion 2710 (i.e., higher condensing when compared to2720). In general gas condenses onto an object when the condensationpoint of the gas is reached, which is a function of temperature. Thuswhen water vapor saturated air at a particular temperature comes intocontact with a cooler material the air at the interface decreases intemperature condensing the water as droplets until the new saturationlevel for the new temperature is reached. For ear wax mitigation,removing the ear wax gas from the environment facilitates keeping it outof acoustic channels. Thus if the acoustic channels can be kept near orhigher than body temperatures (e.g., material made of a good heatconductive material so that the earpiece low condensing regions achievebody temperature quickly), then isolated regions of cooler temperaturescan condense out a portion of the ear wax gas in the closed regionbetween an occluding earpiece and the tympanic membrane. For example ifthe balloon and stent are made of a good thermal conductive polymer,while a light color (e.g., to keep the temperature of the strip down,the light color reflects most incident light) strip of low conductivematerial is attached, then the ear wax gas will have a tendency tocondense on the light strip of non conductive material, removing the earwax gas concentration from the air. If the light colored strip is madeto be easily cleanable then a user can clean the earpiece themselves.

At least one exemplary embodiment is directed to a method of reducingearwax accumulation of acoustic channels comprising: inserting an offsetvolume from at least one acoustic channel, where the offset volume hasat least one dimension larger than the diameter of the acoustic channel(e.g., if the acoustic channel has an inner diameter of 1 mm the offsetvolume has an inner diameter of about 2.5 mm); enclosing the offsetvolume in an enclosure (e.g., molding the waxshield as one piece with anoffset ridge and membrane, where the waxshield can be attached), wherethe enclosure has an opening to the at least one acoustic channel (e.g.,opening in the waxshield can be fit over an acoustic channel to allowacoustic energy into the offset volume); and making at least a portionof the enclosure from a flexible, low air permeable material.

At least one exemplary embodiment is directed to designing a hearing aidthat has an inflation system attached as illustrated and discussed withrespect to FIGS. 9A-9H. At least one exemplary embodiment is directed toa method of hearing aid fabrication comprising: scanning an ear mold andrepresenting the ear mold as an ear mold computer simulation; trimmingthe ear mold computer simulation using software tools to generate ahearing aid simulated body; identifying at least one inflation groove onthe hearing aid simulated body using software tools; and generating amodified hearing aid body simulation with the groove; identifying atleast one inflation channel on the hearing aid simulated body usingsoftware tools; sending the modified hearing aid body simulation to anSLA machine and fabricating a hearing aid body from the SLA machine;attaching an inflation system into the at least one inflation groove;attaching an inflation line into the inflation channel, and attaching aninflation pump to an end of the inflation line.

At least one exemplary embodiment is directed to a hearing aidcomprising: a microphone (e.g., Knowles TO series), a receiver (e.g.,Knowles TWFK version); an inflation tube (e.g., inflation hoops); and aninflating device (e.g., manual and/or electrolysis), where themicrophone samples an ambient environment and replays at least a portionof the ambient environment by the receiver, where the inflation tube isconfigured to expand to seal a channel in which the hearing aid isinserted, where any feedback is reduced by the expanding.

At least one exemplary embodiment is directed to a wax shieldcomprising: a body; a stressed flexible membrane; and where the membraneis attached to the body forming a wax shield, and where the wax shieldis configured to be attached to a device with an acoustic channel, wherethe device is configured to be inserted into an ear canal; andadditionally where the wax shield includes a membrane that has a reducedpermeability to cerumen gas.

At least one exemplary embodiment is directed to a feedback reductionsystem comprising: an acoustic device (e.g., earpiece, hearing aid),which includes a receiver (speaker) and a microphone; and an inflationsystem attached to the acoustic device, where when inflated theinflation system acoustically isolates the microphone from the speakerreducing feedback from the microphone to the speaker.

At least one exemplary embodiment is directed to an increased stabilitymechanism comprising: an inflation system attached to an in-ear device(e.g., earpiece). When the inflation system is inflated the earpiecebecomes more stable (e.g., more resistant to torque, and/or pull).Additionally during jaw motion the inflation system can react bycompressing or expanding when the ear canal dimension changes.

While the present invention has been described with reference toexemplary embodiments, it is to be understood that the invention is notlimited to the disclosed exemplary embodiments. The scope of thefollowing claims is to be accorded the broadest interpretation so as toencompass all modifications, equivalent structures and functions of therelevant exemplary embodiments. For example, if words such as“orthogonal”, “perpendicular” are used the intended meaning is“substantially orthogonal” and “substantially perpendicular”respectively. Additionally although specific numbers may be quoted inthe claims, it is intended that a number close to the one stated is alsowithin the intended scope, i.e. any stated number (e.g., 20 mils) shouldbe interpreted to be “about” the value of the stated number (e.g., about20 mils). Terms such as “left,” “right,” “up,” “down,” “bottom,” “top,”“front,” “back,” “in,” “out,” and like are applicable to the embodimentsshown and described in conjunction with the drawings. These terms aremerely for purposes of description and do not necessarily apply to theposition or manner in which the invention may be constructed for use.

Thus, the description of the invention is merely exemplary in natureand, thus, variations that do not depart from the gist of the inventionare intended to be within the scope of the exemplary embodiments of thepresent invention. Such variations are not to be regarded as a departurefrom the spirit and scope of the present invention.

What is claimed is:
 1. A method of conforming a hearing aid to fit mostusers comprising: attaching an expandable element to a circumferentialgroove of a hearing aid body, wherein the expandable element is seatedin the circumferential groove and does not extend beyond a tip of thehearing aid; attaching an inflation management system to the expandableelement, wherein the expandable element includes an inflatable bladder,and the inflation management system is configured to provide a medium ofa viscous liquid or gel to the bladder, where the inflation managementsystem is electronically controlled by a processor and is not soundactuated pumped; and acoustically isolating a receiver of the hearingaid body by expanding the expandable element after insertion of thehearing aid into the ear, wherein the receiver of the hearing aid bodyis acoustically isolated from a microphone located on an ear apertureside of the hearing aid body, wherein an acoustic signal from the earaperture side of the hearing aid body is acoustically reduced whilepassing the expandable element.
 2. The method according to claim 1,where the medium is silicone, non-permeable based polymers, lowpermeable based polymers, vinyl elastomers, or a combination thereof. 3.The method according to claim 1, wherein the inflation management systemis configured to be manually actuated to expand the expandable elementvia a pneumatic channel that is separate from an acoustic channel in amulti-channel stent coupled to the expandable element.
 4. The methodaccording to claim 1, where the expandable element is configured toencompass a circumferential portion of the hearing aid body whenexpanded.
 5. The method according to claim 4, wherein thecircumferential portion is configured to seal the hearing aid body in anear canal.
 6. The method according to claim 5, further comprising:actuating the inflation management system to increase a first pressurein the inflatable bladder to a second pressure greater than atmospheric.7. A conformal hearing aid comprising: a hearing aid body, wherein thehearing aid body houses a microphone and a receiver, wherein themicrophone is positioned within the hearing aid body to measure acousticsignals from an ambient environment, and wherein the receiver ispositioned within the hearing aid body to emit acoustic signals toward atympanic membrane of a user; an expandable element, wherein theexpandable element is operatively connected to a circumferential grooveof the hearing aid body, wherein the expandable element is configured toencompass a circumferential portion of the hearing aid body whenexpanded, and, wherein the expandable element is seated in thecircumferential groove and does not extend beyond a tip of the hearingaid; and an inflation management system, wherein the inflationmanagement system is configured to expand the expandable element with amedium of a viscous liquid or gel, where the inflation management systemis electronically controlled by a processor and is not sound actuatedpumped, wherein the receiver is acoustically isolated by expanding theexpandable element after insertion of the hearing aid into the ear,wherein the receiver is acoustically isolated from the microphone thatis located on an ear aperture side of the hearing aid body, wherein afirst acoustic signal from the ear aperture side of the hearing aid bodyis acoustically reduced while passing the expandable element.
 8. Theconformal hearing aid according to claim 7, wherein the medium has ahysteresis curve that is less in an operational temperature of theconformal hearing aid than out of the operational temperature of theconformal hearing aid.
 9. The conformal hearing aid according to claim7, wherein the expandable element includes an inflatable bladder that isinflatable via a channel from a multi-channel stent coupled to theinflatable bladder, wherein the multi-channel stent has a separateacoustic channel.
 10. The conformal hearing aid of claim 7, wherein themicrophone is configured to measure an ambient environment, wherein atleast a portion of the ambient environment is replayed by the receiver,where the expandable element is configured to expand to seal a channelthe hearing aid is inserted into, wherein any feedback between themicrophone and receiver is reduced as a result of the sealing of thechannel by the expandable element.
 11. The conformal hearing aidaccording to claim 10 further comprising: a wax shield, wherein the waxshield has at least a portion that is a stressed membrane.
 12. Theconformal hearing aid according to claim 11, wherein the wax shieldincludes a membrane that has a reduced permeability to Cerumen gas thanair at 20 degrees Celsius and a pressure difference across the membraneof 0.1 atm.
 13. A method of distributing force to increase comfort in ahearing aid comprising: attaching an inflatable system to acircumferential groove of a hearing aid, wherein the inflatable systemis seated in the circumferential groove and does not extend beyond a tipof the hearing aid; attaching an inflation management system to thehearing aid, wherein the inflation management system is configured to beactuated, wherein the inflatable system is configured to expand tocontact a portion of an ear canal, and configured so that a pressure ofthe contact can be adjusted by displacement of a medium of a viscousliquid or gel in or out of the inflatable system, where the inflationmanagement system is electronically controlled by a processor and is notsound actuated pumped; and acoustically isolating a receiver of thehearing aid body by expanding the inflatable system after insertion ofthe hearing aid into the ear, wherein the receiver of the hearing aidbody is acoustically isolated from a microphone located on an earaperture side of the hearing aid body, wherein an acoustic signal fromthe ear aperture side of the hearing aid body is acoustically reducedwhile passing the inflatable system.
 14. The method according to claim13, wherein the inflatable system is configured to expand to seal theear canal upon actuation of the inflation management system via achannel from a multi-channel stent coupled to the inflatable system,wherein the multi-channel stent has a separate acoustic channel.
 15. Amethod of distributing force to increase comfort in a hearing aidcomprising: actuating an inflation management system operativelyattached to a hearing aid, where the inflation management system iselectronically controlled by a processor and is not sound actuatedpumped, wherein the actuation of the inflation management systeminflates or expands a bladder attached to a circumferential groove ofthe hearing aid, wherein the bladder is seated in the circumferentialgroove and does not extend beyond a tip of the hearing aid; adjusting apressure in the bladder by displacing a medium of a viscous liquid orgel in or out of the bladder; and acoustically isolating a receiver ofthe hearing aid body by expanding the bladder after insertion of thehearing aid into the ear, wherein the receiver of the hearing aid bodyis acoustically isolated from a microphone located on an ear apertureside of the hearing aid body, wherein an acoustic signal from the earaperture side of the hearing aid body is acoustically reduced whilepassing the bladder.
 16. An adjustable hearing aid comprising: aninflatable system operatively attached to a circumferential groove of ahearing aid, wherein the inflatable system is seated in thecircumferential groove and does not extend beyond a tip of the hearingaid; and an inflation management system operatively attached to thehearing aid, wherein the inflation management system is configured to beactuated, wherein the inflatable system is configured to expand abladder to contact a portion of an ear canal when the inflationmanagement system is actuated, and configured so that a pressure of thecontact can be adjusted by displacement of a medium of a viscous liquidor gel in or out of the bladder, where the inflation management systemis electronically controlled by a processor and is not sound actuatedpumped, wherein the receiver is acoustically isolated by expanding thebladder after insertion of the hearing aid into the ear, wherein thereceiver of the hearing aid body is acoustically isolated from amicrophone located on an ear aperture side of the hearing aid body,wherein an acoustic signal from the ear aperture side of the hearing aidbody is acoustically reduced while passing the inflatable system. 17.The hearing aid according to claim 16, wherein the inflatable system isconfigured to expand to seal the ear canal upon actuation of theinflation management system.
 18. The hearing aid according to claim 16,wherein the inflation management system is configured to adjust thepressure in the bladder via a channel from a multi-channel stent coupledto the inflatable system, the multi-channel stent having a separateacoustic channel.